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820.186
Quality system record.
Each
manufacturer shall maintain a quality system record (QSR). The QSR shall
include, or refer to the location of, procedures and the documentation of
activities required by this part that are not specific to a particular type
of device(s), including, but not limited to, the records required by §
820.20. Each manufacturer shall ensure that the QSR is prepared and approved
in accordance with § 820.40. Interpretation: This document is basically a single list, showing the location of documents (and activities). Many manufacturers fail to have this document approved as is required by the FDA.
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Reference: www.FDA.gov The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation.. |
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